EFS of Posterior Leaflet Replacement to Reduce Mitral Regurgitation (United States)

Starting soon · Not applicable

Conditions studied: Mitral Regurgitation

In brief

The goal of this early feasibility clinical trial is to learn if the device MR-ace Implant and Delivery System works in patients with moderate or severe mitral valve regurgitation. It will also learn about the safety of the device MR-ace Implant and Delivery System. The main questions it aims to answer are: Does implanting the MR-ace device reduce the symptoms of mitral regurgitation? Does the device reduce the the leak through your mitral valve? Participants will: Be implanted with the device Visit the clinic for checkups and tests at 30 days, 6 months, 12 months, and 2, 3, 4 and 5 years following your procedure Complete a quality of life survey

Key facts

Study ID

NCT07517588

Run by

Polares Medical SA

People needed

15

Starts

2026-06-01

Expected to finish

2031-12-31

Last updated by the study team

2026-04-08

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient has symptomatic moderate-to-severe to severe functional mitral regurgitation despite stable doses of maximally tolerated guideline directed medical therapy (GDMT) per the Local Heart Team.
• Note: In the 30 days prior to performing screening assessments, no new GDMT medications should be introduced and current doses should be stable (i.e. no decrease of > 50% or increase of > 100%) excluding diuretics. Any changes beyond this range would not be considered stable GDMT.
• Functional MR graded 3+ or higher (using a scale of 0 to 4+) by transthoracic echocardiography (TTE) within 60 days prior to study procedure as evaluated by the sponsor's Echo Core Lab.
• New York Heart Association (NYHA) Functional Class II, III or ambulatory IV heart failure
• Patient must present with an STS Score less than 10% and deemed by the Local Heart Team to be at high risk but operable for mitral valve surgery.
• The Local Heart Team deems the patient unsuitable for commercially approved transcatheter mitral valve therapies
• 21 years of age or older
• Native mitral valve geometry and size is compatible with the Polares MRace system
• Anatomy is suitable for transfemoral transseptal access with the Polares MRace system
• Patient is willing to participate in study and provides signed IRB/EC-approved informed consent
• Treating physician and patient agree that patient is able to return for all required post-procedure follow-up visits
• Patient is approved by an independent Patient Eligibility Committee

You may not qualify if…

• Echocardiographic parameters (any of the following, assessed by the Echo Core Lab)
• Left ventricular ejection fraction (LVEF) < 30%
• Pulmonary artery systolic pressure (PASP) > 70mmHg or > 2/3 SBP (Systolic Blood Pressure)
• Left Ventricle End Diastolic Volume (LV EDV) > 200 mL
• Left Ventricle End Systolic Volume (LV ESV) > 140 mL
• Left Ventricle End Diastolic Diameter (LV EDD) > 70 mm
• Left Ventricle End Systolic Diameter (LV ESD) > 55 mm
• Severe Right Ventricle (RV) dysfunction as per assessment by Local Heart Team or Eligibility Committee .
• Severe tricuspid regurgitation.
• Severe aortic stenosis or insufficiency.
• Severe mitral annulus calcification.
• Diseased mitral anterior and/or posterior leaflet, such as flail, / prolapse, or/ heavy moderate to severe calcification.
• Barlow's disease.
• Presence of an implanted vena cava filter or any other device (e.g. ASD closure device) that may interfere with femoral vein access or delivery system access to the mitral valve.
• Contraindication for transesophageal echocardiography (TEE) or MDCT scan
• Active infection or endocarditis or infection requiring antibiotic therapy within 2 weeks of scheduled procedure.
• Previous mitral valve surgery or transcatheter mitral valve procedure.
• Prior orthotopic heart transplantation.
• Evidence of intra-cardiac, inferior vena cava (IVC) or femoral venous thrombus. History of deep vein thrombosis (DVT) or pulmonary embolism within 6 months of the index procedure.
• Untreated Class I indication for pacing (CRT). Implant or revision of any pacing device < 30 days prior to intervention
• Any untreated clinically significant coronary artery disease requiring revascularization. Coronary, carotid, or endovascular artery disease treated percutaneously < 30 days prior to study procedure. Cardiac surgery < 90 days prior to study procedure.
• Myocardial infarction requiring intervention < 30 days prior to study procedure
• Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis), hypertrophic or restrictive cardiomyopathies, and constrictive pericarditis)
• Active peptic ulcer or upper gastrointestinal bleeding < 90 days prior to study procedure.
• Stroke < 180 days prior to study procedure.

Full record on ClinicalTrials.gov

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